Personalized health cognitive assistance for stroke rehabilitation

Personalised Health Cognitive Assistance for RehAbilitation SystEm (PHRASE): A Feasibility Study

This study is testing a new gaming system that uses virtual and augmented reality to help stroke patients with their rehabilitation and see if it makes their recovery easier and more effective.

Quick facts

• Study type: Observational
• Enrollment: 150 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Donders Centre for Neuroscience (other)
• Locations: 4 sites (Limoges and 3 other locations)
• Trial ID: NCT06374927 on ClinicalTrials.gov

What this trial studies

This study explores the feasibility of using a Rehabilitation Gaming System (RGS) that incorporates virtual and augmented reality technologies to assist stroke patients in their rehabilitation journey. It aims to evaluate the usability, adherence, user experience, and acceptance of the RGS mobile application, which tracks patient movements and performance to optimize training protocols through AI algorithms. The study collects both quantitative and qualitative data to assess the effectiveness of this innovative approach in enhancing rehabilitation outcomes for stroke patients.

Who should consider this trial

Good fit: Ideal candidates for this study are adults over 18 years old who have experienced an ischemic or intracerebral hemorrhagic stroke and have moderate to mild upper limb motor impairment.

Not a fit: Patients with severe cognitive impairments or other conditions that compromise safety or data quality may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve the rehabilitation process for stroke patients, leading to better recovery outcomes and enhanced quality of life.

How similar studies have performed: While there have been various studies exploring rehabilitation technologies, the specific combination of VR and AR in this context is relatively novel and untested.

Eligibility criteria

Inclusion Criteria:

1. Patients presenting an ischemic or intracerebral haemorrhagic stroke
2. Age \> 18 years old
3. Moderate to mild proximal upper limb motor impairment Medical Research Council Scale (MRC≥2).
4. Lesion localisation by clinical symptoms/signs.
5. Able to sit on a chair or a wheelchair to interact with the RGS system.
6. Minimal experience with smartphone technology based on the clinician's opinion
7. Willing to participate and agree to comply with the trial scheme and procedures
8. Must sign an Informed Consent Form (ICF) indicating that they understand the purpose and the procedures of the study.

Exclusion Criteria:

1. Presence of a condition or abnormality that, in the opinion of the investigator, would compromise the safety of the patient or the quality of the data.
2. Severe cognitive capabilities that prevent the execution of the experiment, either evaluated by the MoCA \< 19 or based on the clinician's opinion.
3. Arteriovenous malformation or lesions not related to a stroke.
4. Severe associated impairments such as proximal but not distal spasticity, communication disabilities (sensory, Wernicke aphasia, or apraxia), major pain, or other neuromuscular impairments.
5. Pre-stroke history of upper limb motor disability.
6. Unable to use the RGS independently according to the clinician's observations and lacking support from a caregiver to use the RGS.
7. Refusal to sign the consent form.
8. No experience with smartphone technology or based on the clinician's opinion.

Where this trial is running

Limoges and 3 other locations

• Centre hospitalier universitaire de Limoges — Limoges, France (NOT_YET_RECRUITING)
• Cluj Rehabilitation Hospital — Cluj-Napoca, Cluj, Romania (NOT_YET_RECRUITING)
• Parc Sanitari Sant Joan de Déu — Barcelona, Spain (RECRUITING)
• IRF La Salle — Madrid, Spain (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: Paul Verschure, PhD

Conditions: Stroke, Rehabilitation, Virtual Reality, Augmented Reality